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【News Releases】Amgen Astellas Biopharma Announces Positive Results From Phase 2 YUKAWA Study of Evolocumab (AMG 145) in Japanese Patients With High Cholesterol

March 24, 2014

YUKAWA Data Showed Evolocumab Reduced LDL Cholesterol Between 64-69 Percent in Statin-Treated Japanese Patients

Data Presented at Japanese Circulation Society Meeting and Simultaneously Published in Circulation Journal

TOKYO (March 24, 2014) – Amgen Astellas Biopharma K.K. (Head Office: Chiyoda-ku, Tokyo, Japan. President: Eiichi Takahashi, hereafter Amgen Astellas) today announced that the Phase 2 YUKAWA (StudY of LDL-Cholesterol Reduction Using a Monoclonal PCSK9 Antibody in Japanese Patients With Advanced Cardiovascular Risk) study evaluating evolocumab met its primary endpoint of the percent reduction from baseline at week 12 in low-density lipoprotein cholesterol (LDL-C). The mean percentage of LDL-C reduction, as measured by the accepted standard, preparative ultracentrifugation, was 69 percent with subcutaneous evolocumab 140 mg every two weeks and 64 percent with evolocumab 420 mg subcutaneous monthly, as compared to placebo. These positive data were reported on March 21, 2014, at the 78^th Annual Scientific Meeting of the Japanese Circulation Society. The same study results were published electronically on March ^21st in the online Circulation Journal of the Japanese Circulation Society.

Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C, or “bad” cholesterol, from the blood.¹

The YUKAWA Phase 2 double-blind, randomized, placebo-controlled study evaluated the safety, tolerability and efficacy of evolocumab in 307 statin-treated Japanese patients at high risk for cardiovascular events. Patients were randomized to one of six treatment groups to compare subcutaneous evolocumab (70 mg and 140 mg every two weeks or 280 mg and 420 mg monthly) with subcutaneous placebo (every two weeks or monthly).

The occurrence of adverse events (AEs) was generally balanced across treatment groups. The three most common AEs were nasopharyngitis, increased creatine phosphokinase and arthralgia. There was no correlation of AEs with evolocumab dose levels or administration intervals.

The lead author, Professor Atsushi Hirayama of Nihon University Graduate School of Medicine, Department of Cardiovascular Medicine, said, “These study results showed that evolocumab, the PCSK9 inhibitor with a novel mechanism of action, improves lipid parameters at the same dose level as overseas studies in Japanese patients. We look forward to the results of the Phase 3 study in Japanese patients (YUKAWA-2) and the multinational collaborative study (FOURIER), which will assess whether treatment with evolocumab in combination with statin therapy compared to placebo and statin therapy reduces recurrent cardiovascular events in approximately 22,500 patients with cardiovascular disease, including Japanese patients.”

The overseas clinical data of evolocumab are scheduled to be presented at the American College of Cardiology’s 63^rd Annual Scientific Session (ACC.14), being held March 29 – 31 in Washington, D.C., USA.

About Evolocumab

Evolocumab (AMG 145) is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).¹ PCSK9 is a protein that targets LDL receptors for degradation and thereby reduces the liver's ability to remove LDL-C, or “bad” cholesterol, from the blood.² Evolocumab, being developed by Amgen scientists, is designed to bind to PCSK9 and inhibit PCSK9 from binding to LDL receptors on the liver surface. In the absence of PCSK9, there are more LDL receptors on the surface of the liver to remove LDL-C from the blood.¹

About Hypercholesterolemia

High cholesterol is the most common form of dyslipidemia, which is an abnormality of lipids in the blood.^3,4 There are approximately 300 million cases of dyslipidemia in the U.S., Japan and Western Europe.⁵ According to the Centers for Disease Control and Prevention, more than 71 million American adults have high LDL-C⁶, or “bad” cholesterol, and elevated LDL-C is recognized as a major risk factor for cardiovascular disease.⁷

About Amgen Astellas BioPharma

Amgen Astellas BioPharma K.K. is a Japanese company that began operations on October 1, 2013, to provide breakthrough-science-based medicines to help address unmet medical needs of patients in Japan. The company is a joint venture between Amgen Inc., the world’s largest independent biotechnology company, and Astellas Pharma Inc., a leading Tokyo-based R&D-oriented global pharmaceutical company. The joint venture will become a wholly-owned Amgen affiliate as soon as 2020. Amgen Astellas BioPharma leverages the capabilities of both companies – Amgen’s science and pipeline candidates coupled with Astellas’ deep knowledge of Japanese patient and physician needs, long-term commercial and regulatory experience, and strong presence as a leading company in Japan – to contribute to the creation of a healthy society.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be the world’s largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

About Astellas

Astellas Pharma Inc. (http://www.astellas.com/jp/) is a pharmaceutical company headquartered in Tokyo, Japan, with total of 17,000 employees. From our business philosophy, we think our mission is “to contribute to the health of people around the world through the provision of highly effective and trustworthy pharmaceuticals.” We are proactive research and development oriented pharmaceutical company that has global reach, and specialize in five research areas: urology, immunology (including transplantation) and infectious diseases, oncology, and diabetes complications and nephrology. We aim to establish ourselves as the global leader in these therapeutic fields.

Amgen Forward-Looking Statements

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen Inc. and its subsidiaries (Amgen) and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen Inc., including Amgen Inc.’s most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen Inc.’s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to Amgen’s business. Unless otherwise noted, Amgen is providing this information as of March 24, 2013 and expressly disclaims any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen and its partners to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with Amgen’s products after they are on the market. Amgen’s business may be impacted by government investigations, litigation and product liability claims. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Amgen depends on third parties for a significant portion of its manufacturing capacity for the supply of certain of its current and future products and limits on supply may constrain sales of certain of its current products and product candidate development.

In addition, sales of Amgen’s products (including products of Amgen’s subsidiaries and collaborations) are affected by the reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others’ regulations and reimbursement policies may affect the development, usage and pricing of Amgen’s products. In addition, Amgen competes with other companies with respect to some of its marketed products as well as for the discovery and development of new products. Amgen believes that some of its newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Amgen’s products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with its products. In addition, while Amgen and its partners routinely obtain patents for their products and technology, the protection of Amgen’s products offered by patents and patent applications may be challenged, invalidated or circumvented by its competitors and there can be no guarantee of Amgen’s or its partners’ ability to obtain or maintain patent protection for Amgen’s products or product candidates. Amgen cannot guarantee that it will be able to produce commercially successful products or maintain the commercial success of its existing products. Amgen’s stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of its products or product candidates. Further, the discovery of significant problems with a product similar to one of Amgen’s products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on Amgen’s business and results of operations. Amgen’s efforts to integrate the operations of companies it has acquired may not be successful.

The scientific information discussed in this news release relating to Amgen’s product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA) or the Japanese Ministry of Health, Labour and Welfare, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

Contacts

Keiko Nakamura (Value, Access and Policy)
Amgen Astellas BioPharma K.K.
Email: Keiko.nakamura@aabp.co.jp
Tel: 03-5293-9870

Chitose Yamada, Communications
inVentiv Medical Communications
Email: Chitose.yamada@inventivhealth.com
Tel: 03-5804-3942

References

1. Amgen Data on File, Investigator Brochure.
2. Abifadel M, et al. Mutations in PCSK9 cause autosomal dominant hypercholesterolemia. Nat Genet. 2003;34:154-156.
3. World Health Organization. Quantifying Selected Major Risks to Health. In: The World Health Report 2002 – Reducing Risks, Promoting Healthy Life. Chapter 4: Geneva: World Health Organization; 2002:47-97.
4. Merck Manuals website. http://www.merckmanuals.com/professional/endocrine_and_metabolic_disorders/lipid_disorders/dyslipidemia.html. Accessed March 2014.
5. National Institute of Health (2006). Federal Register Volume 74 (250). Washington, DC: U.S. Government Printing Office. http://www.gpo.gov/fdsys/pkg/FR-2009-12-31/html/E9-31072.htm. Accessed March 2014.
6. CDC Morbidity and Mortality Weekly Report. Vital Signs: Prevalence, Treatment, and Control of High Levels of Low-Density Lipoprotein Cholesterol --- United States, 1999--2002 and 2005-2008. February 4, 2011. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6004a5.htm?s_cid=mm6004a5_w. Accessed March 2014.
7. American Heart Association (2012). Why cholesterol matters. http://www.heart.org/HEARTORG/Conditions/Cholesterol/WhyCholesterolMatters/Why-Cholesterol-Matters_UCM_001212_Article.jsp. Accessed March 2014.